NCT00210470

A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer

A Phase 2, Open-label Trial of the Safety and Biological Effect of Subcutaneous IRX-2 (With Cyclophosphamide, Indomethacin, and Zinc) in Patients With Resectable Cancer of the Head and Neck

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Brooklyn ImmunoTherapeutics, LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This was a Phase 2a trial to investigate the safety and biological activity of the RIX-2 Regimen in patients with untreated, resectable squamous cell cancer of the head and neck (HNSCC).

Detailed description

IRX-2 is a primary cell-derived biologic that reduces the immune suppression that is often seen in the cancer tumor micro-environment, restores immune function and activates a coordinated immune response against the tumor. IRX-2 is a complex proprietary therapeutic containing numerous active cytokine components, which restores and activates multiple immune cell types including T cells, dendritic cells, and natural killer cells to recognize and destroy tumors. The present study administered the IRX-2 Regimen to 27 patients as a neoadjuvant (before surgery) therapy, and the main objective of the study was to determine the safety and tolerability of the IRX-2 regimen.

Conditions

• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
BIOLOGICAL	IRX-2	IRX-2 for 10 days (2 s.c. injections of 1 mL each day) into bilateral mastoid insertion regions.
DRUG	Cyclophosphamide	Single i.v. injection of low-dose (300 mg/m2) on Day 1
DRUG	Indomethacin	21 days of oral indomethacin, 25 mg. 3 times daily
DRUG	Zinc	21 days of zinc gluconate (65 mg) as part of an oral multivitamin
DRUG	Omeprazole	21 days of 20 mg. orally

Timeline

• Start date: 2005-07-01
• Primary completion: 2010-12-01
• Completion: 2012-03-01
• First posted: 2005-09-21
• Last updated: 2020-12-11
• Results posted: 2012-02-08

Regulatory

• FDA-regulated drug study